Port closure system for intravenous fluid container

ABSTRACT

A port closure system for use with a fluid container having fluid ports includes administrative and additive port closure assemblies. The administrative assembly receives a piercing pin and includes an administrative housing which seals closed one fluid port. A sleeve extends from an interior surface past a base surface in the administrative housing. The sleeve has an upper portion and a lower portion, of differing diameters. A cap assembly mates with the administrative housing, sealing the interior surface of the administrative housing. A removable cap provides access to the interior surface. The additive assembly receives a needle and includes a reseal housing which seals closed another fluid port. Another cap assembly mates with the reseal housing, sealing an interior face of the reseal housing. Another removable cap provides access to the interior face. A reseal element is mechanically retained between the reseal housing and cap assembly.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation of U.S. Ser. No. 11/315,840, whichwas filed Dec. 21, 2005, now U.S. Pat. No. 7,530,974 ,which is acontinuation-in-part of U.S. Ser. No. 11/023,889, which is now U.S. Pat.No. 7,488,311 filed Dec. 23, 2004.

BACKGROUND OF THE INVENTION

The present invention relates to the field of containers foradministering medical fluids to patients. More particularly, the presentinvention relates to a port closure system for intravenous (IV) fluidcontainers.

Access ports are commonly used in infusion solution containers toadminister solutions to a patient, or to add medicaments or othersolutions to the container prior to administration. Current solutioncontainers typically may include a dedicated outlet port for solutionadministration to a patient and a dedicated inlet port for the additionof diluent or other ingredients to the container.

The outlet port is intended to be coupled to an administrative set andis therefore commonly referred to as the administrative port, whereasthe inlet port is designed to permit the injection of therapeutic agentsand nutrients into the partially filled container and is sometimesidentified as the additive port. Such a container may contain a partialfilling of a sterile solution such as saline or dextrose to function asa diluent for the injected additive. The diluted drug or nutrient isthen administered to a patient by means of the administrative set thatmay be either directly or indirectly (i.e., through another solutionset) coupled to the patient.

Maintaining the sterility of the fluid to be administered is of majorimportance. It has been found, however, that careless or inattentivehandling of a solution container, as connections are made for fluidadministration or additive introduction, may create significant risks ofcontamination. Such risks may be increased where emergency situationsare presented that require quick manipulation of the various components.

Autoclave sterilization of the assembled container and ports is time andenergy intensive. The innermost parts of the assembled ports, contactsurfaces and any air voids therebetween that the steam cannot reach aremore difficult to autoclave than the rest of the container. Thetemperature and/or the duration of the autoclave cycle must be increasedfor the difficult to reach areas to be properly sterilized.

Therefore, an object of this invention is to provide an additive portclosure assembly to reduce the possibility of contamination duringstorage and use.

A further object of the invention is to provide an additive port closureassembly to improve the ease of handling when fluids are to be withdrawnor introduced.

Another object of the invention is to provide an additive port closureassembly to increase the ease and efficiency of manufacture.

A further object of the invention is to provide an administrative portclosure assembly to reduce the possibility of contamination duringstorage and use.

A further object of the invention is to provide an administrative portclosure assembly to improve the ease of handling when fluids are to bewithdrawn or introduced.

A further object of the invention is to provide an administrative portclosure assembly that is adaptable to receive administrative sets withspikes or pins of different diameters with consistent insertion andremoval forces and without leakage.

Another object of the invention is to provide an administrative portclosure assembly to increase the ease and efficiency of manufacture.

These and other objects will be apparent to those skilled in the art.

SUMMARY OF THE INVENTION

A port closure system for use with a fluid container having fluid portsmay include administrative and additive port closure assemblies. Theadministrative port closure assembly receives a piercing pin andincludes an administrative housing which seals closed one fluid port. Asleeve extends from an interior surface past a base surface in theadministrative housing. The sleeve has an upper portion and a lowerportion, of differing diameters. A cap assembly mates with theadministrative housing, sealing the interior surface of theadministrative housing. A removable cap provides access to the interiorsurface.

The additive port closure assembly receives a needle and includes areseal housing which seals closed another fluid port. A cap assemblymates with the reseal housing, sealing an interior face of the resealhousing. As with the administrative port closure assembly, a removablecap provides access to the interior face. A reseal element ismechanically retained, secured or captured between the reseal housingand cap assembly.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a partial exploded perspective view of the port closure systemof the present invention in use with a fluid container.

FIG. 2 is a partial perspective view of the port closure system of thepresent invention in use with a fluid container, needle and piercing pinset.

FIG. 3A is a partial sectional exploded view of the port closure systemof the present invention in use with a fluid container.

FIG. 3B is a partial sectional assembled view of the port closure systemof the present invention in use with a fluid container.

FIG. 4 is a sectional view of the additive port closure assembly of thepresent invention.

FIG. 5 is a sectional view of the additive port closure assembly of thepresent invention in use with a needle.

FIG. 6A is a side view of the cap assembly of the present invention.

FIG. 6B is a perspective view of the cap assembly of the presentinvention.

FIG. 6C is an enlarged partial sectional view of the notched portion ofthe cap assembly taken along line 6C-6C in FIG. 6B.

FIG. 7 is a sectional view of the reseal element of the presentinvention.

FIG. 8 is a perspective view of the reseal element of the presentinvention.

FIG. 9 is a sectional view of the administrative port closure assemblyof the present invention in use with a piercing pin set.

FIG. 10 is a cross sectional view of one embodiment of theadministrative port closure assembly of the present invention.

FIGS. 11-15 are cross sectional views of additional administrative portclosure assembly embodiments.

FIGS. 16-17 are perspective views of additional port closure systemembodiments.

FIG. 18 is a cross sectional view similar to FIG. 4 of an alternativeembodiment of the additive port closure assembly.

FIG. 19 is an enlarged partial cross sectional view of a portion of theadditive port closure assembly from FIG. 18 prior to the cap assemblybeing joined to the reseal housing.

FIG. 20 is an enlarged partial cross sectional view of the additive portclosure assembly and shows the area encircled by the line 20-20 in FIG.18. FIG. 20 is similar to FIG. 19 but shows the same area after the capassembly is joined to the reseal housing.

DETAILED DESCRIPTION OF THE EMBODIMENTS OF THE INVENTION

With reference to FIGS. 1-3A, a port closure system 10 is shown for usewith a fluid container 12, which may have first and/or second fluidports 14 and 16 accessible respectively with a syringe needle 18 andpiercing pin set 20. Fill tubes 13, 15 define the fluid ports 14 and 16respectively.

With reference to FIGS. 2-5, the port closure system 10 includes twoport closure assemblies; with the first port assembly being an additiveport closure assembly 22 adapted to provide needle 18 sterile access tothe first fluid port 14. The additive port closure assembly 22 isadapted to be assembled and sterilized as a subassembly prior toassociation and use with the fluid container 12.

The additive port closure assembly 22 includes a port housing 24(hereinafter “reseal housing 24”) adapted to seal closed the first fluidport 14 by attachment to the fill tube 13. The reseal housing 24 has abase face 26 adapted to be associated with the first fluid port 14 orfill tube 13 and an interior face 28 adapted to face outwardly from thefirst fluid port 14. An open cylinder 30 extends from the interior face28 to the base face 26 and has an upper rim 32. A reseal diaphragm 34 isconnected to the open cylinder 30 to seal the open cylinder 30 closed tofluid flow from the container 12. The reseal diaphragm 34 is opened tofluid flow once pierced by needle 18. A reseal flange 36 extendsgenerally radially from the open cylinder 30. The reseal flange 36protects the user from accidental pricks when applying needle 18 to theadditive port closure assembly 22.

The reseal flange 36 and open cylinder 30 are also oriented and arrangedto accommodate a commercially available needle-less access system (notshown) being integrated with the reseal housing 24. U.S. Pat. No.5,924,584 describes one embodiment of a needle-less access systemsuitable for the present invention; said description is expresslyincorporated herein in its entirety.

With reference to FIGS. 3A-6C, a cap assembly 38 of additive portclosure assembly 22 is connected to the reseal housing 24. In general,the cap assembly 38 includes an under shell 40 shaped to mate with theinterior face 28 of the reseal housing 24. Once mated, the cap assembly38 seals the interior face 28 from potential contamination. A sealedopening 42 is provided in cap assembly 38, and a removable cap 44provides access to the sealed opening 42 and the interior face 28. Oncethe removable cap 44 is detached, the additive port closure assembly 22need not be re-sterilized, as the cap assembly 38 operates as a sterilebarrier to shield the interior face 28 from potential contamination.Removable cap 44 is tamper evident as it cannot be reconnected onceremoved. Furthermore, if the cap 44 is pierced while still in place, itclearly shows that a hole has been made in the cap (i.e., tampering hastaken place).

The cap assembly 38 is of unitary construction and includes a crown 46connected to the removable cap 44 by an annular frangible area 48. Theterm “frangible area” as used herein refers to any breakable area or anyarea with some form of breakable seal.

The crown 46 of the cap assembly 38 has an outer shell 50. The sealedopening 42 extends between the outer and under shells 50 and 40 andprovides access to the interior face 28 when the removable cap 44 isdetached. A retaining rim 54 extends from the under shell 40 and aroundthe sealed opening 42. A crown flange 56 extends generally radially fromthe sealed opening 42. The crown flange 56 protects the user fromaccidental pricks when applying needle 18 to the additive port closureassembly 22.

A notch area 58 is formed on the cap assembly 38 and is operativelyassociated with the frangible area 48 to weaken the frangible area 48near the notch area 58. One skilled in the art will appreciate that thenotch area 58 can be on the removable cap 44, as shown in FIG. 6C, or onthe crown 46 without detracting from the invention. The notch area 58can be formed in a variety of force focusing shapes, including but notlimited to a partial pyramid shape, a V-shape, or a partial conicalshape.

A cover 60 of the removable cap 44 is sealed over the sealed opening 42by the frangible area 48. The cover 60 has a thickness sufficient toresist manual piercing by needle 18 or piercing pin 20. Due to the melttemperature of the material of the cover 60 being in the range of129-144° C. and the presence of an air chamber under the cover onceassembled, the cover 60 is adapted to shape changes during heatsterilization, which allows a user to discern the sterilized state ofthe additive port closure assembly 22 due to the shape of cover 60.

A pull element 62 of the removable cap 44 is connected to the cover 60to allow a user to manually tug on the pull element 62 to sever thefrangible area 48 and separate the cover 60 from the crown 46. The pullelement 62 includes a lever 64 connected to one side of the cover andadjacent to the crown 46. The lever 64 is positioned adjacent the notcharea 58 and focuses the user tugging force on the pull element 62 at thenotch area 58. The lever 64 includes an area of narrowed cross sectionthat defines a pull force concentrator. The pull force concentrator isadjacent the frangible area 48 and near the notch area 58. Preferablythe pull force concentrator is defined by a transverse groove 65 havingrounded side walls in the top of the lever 64, although other shapes,orientations and locations will not detract from the invention so longas the structure focuses or concentrates the user tugging force on thepull element at the notch area 58.

A pull tab 66 is connected to the lever 64 by a pull ring 68 andpositioned opposite the lever 64 on the pull ring 68. The pull tab 66provides an area for a user to manually grip and tug on the pull element62.

At least one pivot element 70 is radially spaced from the frangible area48 and circumferentially spaced from the lever 64 on the pull ring 68.More preferably, a pair of pivot elements is positioned so each pivotelement is equally spaced about ninety degrees away from the lever 64.The pivot elements 70 contact the crown 46 and pivot to absorb anyimpact forces on the pull element 62 to prevent inadvertent damage tothe frangible area 48. Additional pivot elements may be utilized asneeded.

With reference to FIGS. 3A, 4, 5 and 7, a reseal element 72 of theremovable cap 44 is positioned between the under shell 40 of the crown46 and the interior face 28 of the reseal housing 24. The reseal element72 has an annular shoulder 74 extending radially from a central core 76.The annular shoulder 74 splits the central core 76 into an upper core 78having a raised surface 80 and a lower core 82.

The raised surface 80 extends beyond the sealed opening 42 in the capassembly 38 when the removable cap 44 is detached. The exposed raisedsurface 80 provides a convenient swabbable area to sterilize duringsubsequent uses.

The lower core 82 is received within the open cylinder 30 of the resealhousing 24. The diameter of the lower core 82 is selected relative tothe diameter of the open cylinder 30 such that the open cylinder 30presses radially inward on the lower core 82 to provide a sealtherebetween and to re-seal the reseal element 72 itself when punctured.In other words, the lower core 82 is frictionally fitted or forciblypressed into the open cylinder 30 of the reseal housing 24. Thisfrictional fit provides one means of securing or retaining the resealelement 72 in the reseal housing 24 for subsequent assembly operations.

An annular lip element 84 is connected to an outer rim 86 of the annularshoulder 74. The junction of the rim 86 and the lip element 84 has afillet or inside radius 85. The lip element 84 extends transversely tothe annular shoulder 74 in two directions. The upper and lower insideedges of the lip element 84 have a chamfer, inside radius or fillet 87thereon to assist in molding and guide the retaining rim 54 or rim 32toward the annular shoulder 74. The annular lip element 84 has an insidediameter greater than the outside diameter of the retaining rim 54 andan outside diameter less than the outer diameter of the crown flange 56.The reseal element 72 is mechanically retained, held, secured, or moreparticularly clamped in place by the retaining rim 54 of the crown 46and the upper rim 32 of the open cylinder 30, which upon the capassembly 38 and reseal housing 24 being connected together are receivedbetween the central core 76 and the lip element 84 so as to retain theannular shoulder 74. The uncompressed height of the annular shoulder 74can be selected to be equal to, or more preferably greater than, thedistance between the retaining rim 54 and the rim 32 when the cap 44 andreseal housing 24 are joined. Selecting an uncompressed height greaterthan the available distance provides a desirable clamping force orsealing on the resilient material of the reseal element 72 at theshoulder 74. Alternatively, there may initially be a small gap betweenthe retaining rim 54 and the upper surface of the shoulder 74. The gapmay remain or be eliminated when, upon heat sterilization of theassembly 22, the cap 44 deforms. In the latter case, the rims 32, 54abut or contact the lower surface and upper surface respectively of theannular shoulder 74. Thus, the crown 46 and the reseal housing 24, alongwith the annular shoulder 74 and the lip 84 of the reseal element,cooperate to provide a substantially permanent mechanical second meansof securing the reseal element 72, which can be independent of the fitbetween the reseal element 72 and the open cylinder 30 and eliminatesthe need for separate fasteners, solvent bonding or swaging the resealelement 72 in place. In addition to positively retaining the resealelement 72 in place, the cap assembly 38 provides a removable cap 44that seals the reseal element 72 from contamination until use. Despitethe fact that the reseal element 72 is neither solvent bonded nor swagedinto place, its securement is unaffected by component size, needlegauge, insertion force on the needle 18 or the removal of the cap 44.The reseal element 72 is automatically mechanically retained in placeand constrained against movement both axially and radially primarily bythe connection of the crown 46 and reseal housing 24.

With reference to FIGS. 1-3B, 9, and 10, an administrative port closureassembly 88 is shown as the second port closure assembly of the portclosure system 10. The administrative port closure assembly 88 isadapted to provide piercing pin set 20 sterile access to the secondfluid port 16. The administrative port closure assembly 88 is alsoadapted to be assembled and sterilized as a subassembly prior toassociation and use with the fluid container 12.

With reference to FIGS. 1, 9 and 10, the administrative port closureassembly 88 includes a second port housing 90 (hereinafter“administrative housing 90”) adapted to seal closed the second fluidport 16 by attachment to the fill tube 15. A base surface 92 is adaptedto be associated with the second fluid port 16 or fill tube 15 and aninterior surface 94 is adapted to face outwardly from the second fluidport 16.

A seal ring 95 extends from the base surface 92 and is adapted to besealably received within the second fluid port 16. The seal ring 95 hasa stiff construction and large diameter of about ⅝″ to provide improveduser handling of administrative port closure assembly 88. An optionalstiffening hoop or rib 97, more preferably a pair of spaced ribs 97,extends radially inwardly on the seal ring 95 to stiffen the seal ringand resist deformation during heat sealing to the port 16 and laterautoclave heat sterilization.

A sleeve 96 extends from the interior surface 94 past the base surface92 and within the seal ring 95. The sleeve 96 is recessed below sealedopening 42 of second cap assembly 38 connected to the administrativehousing 90. This recess protects the sleeve from inadvertentcontamination of interior surface 94 when the administrative portclosure assembly 88 is opened. The sleeve 96 has an upper portion 98 anda lower portion 100. The upper portion 98 is adjacent the interiorsurface 94 and has an opening 104 with a lesser diameter than the lowerportion 100. The diameter difference between the upper and lowerportions 98 and 100 allows the sleeve 96 to receive and sealablyassociate with differently sized piercing pin sets 20, and toaccommodate diameter variation among various piercing pin sets 20.

In the embodiment disclosed in FIG. 10, the upper portion 98 has asubstantially uniform wall thickness and is tapered inwardly into abullet nose configuration where the exterior surface is convex and theinterior surface is concave. The taper can be formed by any number ofwell-known manufacturing techniques, including but not limited tocutting, rolling (with or without heat) and swaging. The taper of theupper portion 98 is preferably curvilinear, but linear taper can also beused. During use the user's fingers are within ¼″ of the sleeve 96,allowing the user to easily control the position of the sleeve 96 withrespect to piercing pin sets 20.

The sleeve 96 and the seal ring 95 are connected at a flexible annularjunction 102 at a base 114 for the sleeve to form a unitary body. Theflexible junction 102 allows for some minor displacement of the sleeve96 with respect to the rigid seal ring 95 during use.

An air-filled moat 106 is positioned between the seal ring 95 and thesleeve 96 on the base surface 92. The moat 106 allows the seal ring 95to contract and expand as needed based on internal pressure of thecontainer 12 during the heat sterilization cycle. Thus, the moat 106protects the sleeve 96 from significant permanent deformation that couldlead to leaks or unacceptable insertion or withdrawal forcerequirements. The connection between the seal ring 95 and sleeve 96provides a clamping or sealing force on piercing pin set 20 (not shown)during pin insertion and withdrawal. In addition to being physicallyseparated from the sealing ring 95 except at the base 114, the sleeve 96is protected by the seal ring 95 and moat 106 from potential distortionduring autoclaving, since the moat 106 reduces outside pressure againstsleeve 96 during autoclaving.

An administrative diaphragm 110 is connected to the sleeve 96 to sealthe sleeve 96 closed to fluid flow. The administrative diaphragm 110 isopened to fluid flow once pierced by piercing pin set 20.

An administrative flange 112 extends generally radially from the sealring 95, and thus from the sleeve 96. The administrative flange 112around the sleeve 96 creates an effective target area for the user toapply the piercing pin set 20 toward and protects the user fromaccidental pricks.

A second cap assembly 38 is connected to the administrative housing 90to form the administrative port closure assembly 88. The under shell 40is shaped to mate with the interior surface 94 of the administrativehousing 90. Once mated, the cap assembly 38 seals the interior surface94 from potential contamination. The removable cap 44 provides access tothe sealed opening 42 and thus the interior surface 94. Once theremovable cap 44 is detached, the administrative port closure assembly88 need not be re-sterilized, as the cap assembly 38 operates as asterile barrier to shield the interior surface 94 from potentialcontamination.

With reference to FIG. 1, during manufacture of the port system 10, porthousings 24/90, cap assembly 38 and reseal element 72 are mold formed.The additive port closure assembly 22 is formed by positioning resealelement 72 between the cap assembly 38 to the port housing 24, andpermanently connecting the cap assembly 38 to the port housing 24. Theadministrative port closure assembly 88 is formed by connecting the capassembly 38 to the port housing 90. Port closure assemblies 22/88 areconnected together by ultrasonically welding or radiant thermofusionwelding the cap assembly 38 to the port housing 24/90. Port closureassemblies 22/88 are sterilized by irradiation. The irradiatedpre-sterilized port closure assemblies 22/88 form subassemblies that aresubsequently associated with or attached to the fluid container 12. Thefluid container 12 is sealed to the irradiated port closure assemblies22/88 by conventional means, including but not limited to ultrasonicallywelding, radiant thermofusion welding, or hot tongue heat sealing. Theassociated port closure assemblies 22/88 and fluid container 12 are thenterminally heat sterilized by autoclaving after filling.

Port closure assemblies 22/88 are formed of a polymer blend that doesnot degrade during the irradiation, sterilization, radiant thermofusionwelding, and ultrasonic welding. The term “degrade” as used hereinrefers to degradation to such an extent that the material is no longersuitable for its intended purpose. The polymer blend also providesultrasonic sealability, radiant thermofusion sealability, and preventscoring when the polymer is punctured. The term “coring” as used hereinrefers to the process of a polymer fragmenting upon piercing so as toresult in the formation of loose polymer particulate. The ability ofpolymer blend to be sealed by ultrasonic bonding and/or radiantthermofusion eliminates the need for any solvent or swaged bonding; andalso eliminates the need to provide additional frictional force fitcomponents to hold the port closure system 10 together. Additionally,the polymer blend provides a balance between insertion and withdrawalforces for improved handling by users.

One example of such a polymer blend includes but is not limited to ablend of 70% commercially available Atofina Z9470 and 30% commerciallyavailable Basell KS359P. Other suitable polypropylene copolymers andpolyethylene copolymer blend could also be used without departing fromthe present invention.

Materials are selected for the IV fluid container 12, fill tube 13, 15,port housings 24, 90, and cap assembly 38 to provide, in conjunctionwith their design, the required container and port system functionality.While the difference in function among these parts requires differentphysical properties that may be supplied by a variety of materials, thematerials must be compatible on a molecular level to enable them to bejoined together without adhesives.

The fill tube 13, 15 is formed of a material that is sealable to theinner sealant surface of the IV fluid container 12 and the port housings24, 90. It must be able to be autoclaved without deformation thatsignificantly affects its appearance or function of providing a channelbetween the container 12 and the ports 14, 16. For sealant surfaces ofcontainers 12 and port housings 24, 90 that comprise olefins such aspolypropylene homopolymers, polypropylene copolymers, or blends ofpolypropylene copolymers with materials providing elastomericproperties, the fill tube 13, 15 preferably comprises a polypropylenehomopolymer or copolymer. A homopolymer provides better dimensionalstability through autoclaving, while a copolymer provides bettercompatibility with an IV container 12 that has a copolymer sealantsurface. For container sealant surfaces and port housings that compriserandom polypropylene copolymers or blends of random polypropylenecopolymers with materials providing elastomeric properties, the filltube 13, 15 preferably comprises a random polypropylene copolymer withethylene content from about 2% to about 6% and a melting point fromabout 129° C. to about 145° C. To reduce deformation with autoclaving at125° C., the random polypropylene copolymer more preferably has anethylene content of about 2% and a melting point of about 145° C.Specifically, a random polypropylene copolymer, Atofina 7825, has beenfound to produce the best results at autoclave temperatures up to about125° C. with a container 12 with polypropylene copolymer sealant layerand port housings 24, 90 comprising a blend of polypropylene copolymers.

The administrative port housing 90 must be heat sealable to both thefill tube 13 and cap assembly 38, as well as be stable to gammaradiation from 18-45 kGy, more preferably from 18-32 kGy. Theadministrative port housing 90 must be autoclavable up to about 125° C.without deformation that significantly affects its function of beingable to accept and retain a piercing pin 20 with acceptable forces.Preferably the material selected for the administrative port housing 90has a high melt temperature and good elastomeric properties. A materialblend is preferred to provide properties not available from individualmaterials. A polypropylene based material is preferred primarily for itschemical compatibility with the polypropylene fill tube 13. Furthermaterial selection is dependent on radiation stability, autoclavetemperature, and the range of piercing pin diameters to be used.Generally, polypropylenes with higher melting points such ashomopolymers or copolymers with low ethylene content, for exampleAtofina 7825 that has 2% ethylene content, withstand autoclaving withless deformation. However, they have relatively high moduli, whichincreases piercing pin insertion force and limits the range of piercingpin diameters that may be used. They are also less stable to gammaradiation unless purposely stabilized with additives. While theirperformance may be improved by blending them with lower moduli,radiation stable olefins, it is preferable to use a high ethylenecontent (about 6% or greater) random copolymer as the base material. Thehigh ethylene content improves radiation stability and lowers themodulus while maintaining acceptable resistance to autoclavedeformation. It also reduces the concentration of the softening materialrequired. Such softening material often has a lower melting point or istacky and difficult to injection mold. Preferably a high ethylenecontent random polypropylene copolymer, such as Atofina Z9470, is usedfor the base material.

While an unmodified high ethylene content random polypropylene copolymermay provide acceptable performance with a single piercing pin diameter,it is preferable to soften the material with polyolefin copolymers suchas thermoplastic polyolefin elastomers (TPEs) to broaden the range ofacceptable piercing pin diameters and improve radiation stability.Acceptable performance also may be obtained with low ethylene contentpolypropylene random copolymer base materials with an appropriateselection of TPE and blend ratio. Similar to polypropylene copolymers,softer TPEs generally have lower melting points. Ethylene-hexene andethylene-octene copolymer flexomers have very low moduli and meltingpoints (72° C. and 55° C., respectively) substantially below theautoclave temperature of 125° C. However, when blended with a lowethylene content random copolymer at a ratio of 70% polypropylenecopolymer/30% flexomer, they provide adequate softening and autoclavedimensional stability. An ethylene-octene flexomer, such as Dow AffinityEG8100, is preferred to reduce piercing pin insertion force.Polypropylene random copolymers with ethylene-propylene rubberscopolymerized in the copolymer matrix, such as Basell's Adflexmaterials, provide less softening than flexomers but have higher melttemperatures (approximately 144° C.). They are highly suitable forsoftening a high ethylene content random polypropylene copolymer basematerial, such as Atofina Z9470, because they reduce stiffness withoutreducing autoclave dimensional stability. Basell Adflex KS359P is onematerial that has been found to provide effective softening andradiation stability. Blends made from 40% Z9470/60% KS359P to 70%Z9470/30% KS359P may be used, with blends of about 70% Z9470/30% KS359Pbeing more preferred.

The port cap assembly 38 must be sealable to both the administrative andadditive port housings 90, 24 and stable to gamma radiation from 18-45kGy, more preferably from 18-32 kGy. It must be autoclavable up to about125° C. without deformation that significantly affects its function ofmaintaining sterility and being opened with an acceptable pull force.Key to an acceptable opening performance is developing an appropriatecombination of material stiffness and tear detail thickness. The pullring 68 or pull element 62 may snap off prior to opening the cap 44 withan excessively stiff material or thick tear detail. The pull ring 68 maystretch without opening the cap 44 or the cap 44 may deform duringautoclaving with a material that is too soft. Materials that minimallyprovide the required properties are high ethylene content polypropylenecopolymers such as Atofina Z9470 and random heterophasic polypropylenessuch as Borealis Bosrsoft SD233CF. However, it is preferred to lower theopening force by using a TPE modifier. To maximize sealability to theadministrative port housing 90, it also is preferred that the samematerials be used in the same or similar ratio as used in the porthousing 90. Basell Adflex KS359P again is highly suitable in that itprovides softening without a loss in autoclave dimensional stability. Arange of 100% Z9470/0% KS359P to 70% Z9470/30% KS359P is acceptable,with 70% Z9470/30% KS359P being more preferred.

Similar to the administrative port housing 90, the additive port housing24 must be sealable to both the fill tube 13 and cap assembly 38 andstable to gamma radiation from 18-45 kGy, more preferably from 18-32kGy. It must be autoclavable up to about 125° C. without deformationthat significantly affects its function of being able to be pierced by aneedle 18 without coring. To resist coring, it is preferred that theselected material has elastomeric properties. Polypropylene randomcopolymers with ethylene-propylene rubbers copolymers copolymerized inthe copolymer matrix, such as Basell Adflex materials, are elastomericand sealable to the 70% Z9470/30% KS359P port cap. Adflex KS359P ispreferred among the Adflex materials for coring performance because itis the most elastomeric in the current Adflex product line. To improveseal strength by maximizing chemical compatibility and to improveejection during injection molding, it is preferred to use the samematerials in the same 70%/30% blend ratio as the cap assembly 38. Tomaximize coring performance at the intended port diaphragm 34 thicknessof 18 mils, a range of 40% Z9470/60% KS359P to 0% Z9470/100% KS359P ispreferred. To optimize injection molding, sealing, and coringperformance, a 40% Z9470/60% KS359P blend is more preferred. The rangemay be adjusted depending upon diaphragm thickness, with thickerdiaphragms generally requiring a higher elastomeric concentration. Theblend of resins used for the various parts to be sonic or heat weldedmust provide melting points that are not so dissimilar as to preventproper sealing security or reliability.

With reference to FIG. 11, a still further embodiment of administrativeport closure assembly 88 includes many of the same features as theembodiment of FIG. 10, but instead of the tapered sleeve end furtherincludes a small wiper 116 adjacent the aperture 104 of sleeve 96 toseal against piercing pin set 20 (not shown). The sealing of the wiper116 against the piercing pin set 20 (not shown) reduces the chance forfluid to leak out during activation. It will be understood to thoseskilled in the art that various methods including but not limited toswaging at the aperture 104 could be used to form the wiper 116. Thewiper 116 could also be combined with a tapered sleeve end of FIG. 10.

With reference to FIG. 12, a still further embodiment of administrativeport closure assembly 88 includes some of the features of the embodimentof FIGS. 9-11 but further includes a pre-pierced administrative sealwasher 118 having a wiping diameter 119, retained, secured, held, ormore particularly (especially once heat sterilized) clamped in placebetween the retaining rim 54 and an administrative rim 120 extendingfrom shoulder 102. The administrative seal washer 118 seals againstpiercing pin set 20 (not shown). To moderate and balance the forcesrequired to insert and withdraw the pin set 20, the wiping diameter 119can be centrally located and the pre-pierced diameter can be graduallyincreased as distance from the wiping diameter increases.

With reference to FIG. 13, a still further embodiment of administrativeport closure assembly 88 includes some of the features of the embodimentof FIG. 12 but includes an administrative reseal 118A similar to thereseal element 72 of the additive port closure assembly 22, retained,secured, held, or more particularly clamped in place between theretaining rim 54 and an administrative rim 120 extending from shoulder102. Similar to the reseal element in the additive port closure assembly22, the administrative reseal 118A is clamped by the rims 54 and 120,especially once the assembly 88 is heat sterilized. The administrativereseal 118A seals against piercing pin set 20 (not shown). Since thereseal element 118A completely seals the opening 104 of the sleeve 96,the diaphragm 110 is optionally excludable in this embodiment. Thecentral diaphragm 121 of the reseal 118A is relatively thick (greaterthan 0.050 inch or 1.27 mm) in the embodiment of FIG. 13. A stillfurther embodiment can combine the features of FIGS. 12 and 13 so thatthe reseal element 118A includes a thin (0.010-0.050 inch or 0.254-1.27mm) central diaphragm 121 rather than a pre-pierced opening or wipingdiameter 119 or the thick central diaphragm 121 of at least 0.050 inchor 1.27 mm shown in FIG. 13. This thin diaphragm configuration isadvantageous in that it makes the reseal element easier to mold and doesnot leave flash in undesirable areas.

With reference to FIG. 14, a still further embodiment of administrativeport closure assembly 88 includes some of the same features as theembodiment of FIG. 10, but further includes an either injection moldedor extruded administrative sealing washer 118B with an inner diameter119A that seals against piercing pin set 20 (not shown). The sealingwasher 118B is retained, secured, held, or more particularly (especiallyonce the assembly is heat sterilized) clamped in place between theretaining rim 54 and the sleeve 96.

With reference to FIG. 15, a still further embodiment of administrativeport closure assembly 88 includes a small wiper 116 similar to theembodiment of FIG. 11, but the wiper 116 and sleeve 96 form a unitarybody that is molded through co-injection molding so that small wiper 116has a different polymer content than sleeve 96. The wiper 116 is formedof isoprene and will generate holding forces during activation with thepiercing pin set 20 (not shown).

With reference to FIG. 16, another embodiment of port closure system 10replaces cap assemblies 38 with cover foils 122. The cover foils 122 aremade of pealable film stock. In this embodiment reseal element 72 isswaged in place. A body portion 124 joins the administrative portassembly 88 and additive port assembly 22.

With reference to FIG. 17, a further embodiment of port closure system10 includes the same features as the embodiment of FIG. 16, and furtherincludes a handle element 126 joining the port assemblies 22, 88 so asto define a space 127 between the handle portion 126 and the fluidcontainer 12, thus permitting a user to loop fingers around handleportion 126. Additionally, additive port assembly 22 is sized smallerthan administrative port assembly 88 and is positioned lower withrespect to the administrative port assembly 88, to further distinguishthe additive port assembly 22 from the administrative port assembly 88.

With reference to FIGS. 18-20, a further embodiment of the additive portclosure assembly 22 includes a reseal housing 24 and reseal element 72as described above. However, the under shell 40A of the cap assembly 38differs in some respects from the under shell 40 previously described.The under shell 40A of the crown 46 includes at least one sealingelement 150 for engaging the lip 84 of the reseal element 72. Preferablythe sealing element 150 engages the top surface 89 of the lip 84.

Although one skilled in the art will appreciate from this disclosurethat the sealing element 150 can take various forms and shapes, in theembodiment shown, the sealing element 150 includes at least oneprotrusion 152 that extends downwardly from the under shell 40A anddefines troughs 154, 156 on either side thereof. The protrusion 152 canbe generally V-shaped in cross section and have angled sides 158, 160that converge to form a blunt, rounded tip 162. Preferably theprotrusion 152 extends around the under shell 40A in a circular pattern.The circular pattern can be broken to form circumferentially spacedprotrusions or can be unbroken to form a continuous annular protrusion.Alternatively, the sealing element 150 can include a plurality ofconcentrically arranged protrusions 152.

As best seen in FIG. 20, the sealing element 150 engages the lip 84between the under shell 40A and the interior or inner surface 28 whenthe under shell 40A of the crown 46 is connected, attached or joined tothe inner surface 28 of the reseal housing 24 as described above. Thetip 162 and angled sides 158, 160 of the protrusion 152 or sealingelement 150 contact and sealingly engage the top surface 89 of the lip84. The reseal element 72 resiliently deforms around the protrusion 152.The engagement of the protrusion 152 with the resilient reseal element72 provides a clamping force on the lip 84, clamping it between theprotrusion 152 on the under shell 40A and the inner surface 28 of thereseal housing 24. When the sealing element 150 includes one or moreprotrusions 152 arranged a sufficiently closed annular pattern, thisarrangement provides an effective seal against liquids, vapors and gasesthat might otherwise pass around the reseal element 72. The inventionassists in preventing contamination from reaching the inner surface 28when the user removes the detachable cap 44. Undesirable ingress andegress of liquids, vapors or gases is prevented during the sterilizationof the port closure assembly 22 or the fluid container 12 to which theport closure assembly is attached. This embodiment of the inventionprovides the additional benefit of further restraining the resealelement 72 against movement that might otherwise occur during insertionor withdrawal of a needle 18 or similar piercing member.

One skilled in the art will appreciate that the principles of FIGS.18-20 can be applied alone or in combination with other featuresdisclosed herein. By way of example and not limitation, the principlesare applicable to administrative port closure assemblies that utilize areseal element, such as the embodiment of FIG. 13.

From the foregoing, it can be seen that the present inventionaccomplishes at least all of the stated objectives. The inventionprovides a port closure system that reduces the possibilities ofcontamination during storage and use, improves the ease of handling whenfluids are to be withdrawn or introduced, and increases the ease andefficiency of manufacture.

1. A port closure system for use with a piercing pin and a fluidcontainer having a fluid port, comprising: an administrative housingadapted to seal the fluid port in closed condition, the administrativehousing having a base surface adapted to be associated with the fluidport and an interior surface adapted to face outwardly from the fluidport, a sleeve extending from the interior surface past the basesurface, and a diaphragm connected to the sleeve to seal the sleeveagainst fluid flow; the sleeve having an upper portion and a lowerportion, the upper portion being adjacent the interior surface andhaving an opening with a lesser diameter than the lower portion, and thediameter variation between the upper and lower portions permitting thesleeve to receive and sealably associate with the piercing pin duringuse regardless of the diameter of the piercing pin; and a cap assemblyconnected to the administrative housing, the cap assembly including anunder shell shaped to mate with the interior surface of theadministrative housing to seal the interior surface, and a removable capwhich provides access to a sealed opening located over the sleeve;wherein the base surface includes a seal ring and a moat, the seal ringadapted to be sealably received within the fluid port, the moat beingpositioned between the seal ring and the sleeve.
 2. The port closuresystem of claim 1, wherein the administrative housing and cap assemblyform a port assembly adapted to be assembled and pre-sterilized as asubassembly prior to association and use with the fluid container, andwherein the port closure system is adapted to be heat sterilized withthe fluid container after the fluid container is filled.
 3. The portclosure system of claim 1, wherein the sleeve is recessed below thesealed opening in the cap assembly and prevents accidental contaminationof the sleeve.
 4. The port closure system of claim 1, wherein the upperportion of the sleeve includes a wiper adjacent the opening, the wiperhaving an inside diameter smaller than the diameter of the opening. 5.The port closure system of claim 4, wherein the wiper is formed from adifferent material than the sleeve and is co-injection molded on thesleeve.
 6. The port closure system of claim 1, wherein the upper portionof the sleeve tapers inwardly.
 7. The port closure system of claim 6wherein the upper portion of the sleeve tapers curvilinearly inward toform an exterior surface that is convex.
 8. The port closure system ofclaim 7 wherein the upper portion of the sleeve has a uniform wallthickness and a sleeve interior surface that is concave.
 9. A portclosure system for use with a piercing pin and a fluid container havinga fluid port, comprising: an administrative housing adapted to seal thefluid port in closed condition, the administrative housing having a basesurface adapted to be associated with the fluid port and an interiorsurface adapted to face outwardly from the fluid port, a sleeveextending from the interior surface past the base surface, and adiaphragm connected to the sleeve to seal the sleeve against fluid flow;the sleeve having an upper portion and a lower portion, the upperportion being adjacent the interior surface and having an opening with alesser diameter than the lower portion, and the diameter variationbetween the upper and lower portions permitting the sleeve to receiveand sealably associate with the piercing pin during use regardless ofthe diameter of the piercing pin; and a cap assembly connected to theadministrative housing, the cap assembly including an under shell shapedto mate with the interior surface of the administrative housing to sealthe interior surface, and a removable cap which provides access to asealed opening located over the sleeve; wherein the upper portion of thesleeve tapers curvilinearly inward, has a uniform wall thickness, andhas a sleeve interior surface that is concave for sealingly engaging thepiercing pin.